Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth; Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth

• Registration Number: NCT00469638
• Lead Sponsor: Abbott Medical Devices

Brief Summary

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.

Detailed Description

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.

Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Paroxysmal or persistent symptomatic atrial fibrillation
• Resistant to at least 1 anti arrhythmic drug
• Left atrial diameter less then 60 mm (TTE, parasternal)
• Atrial fibrillation documented by ECG
• Patient is willing and available to perform all Follow Ups

Exclusion Criteria

• Permanent atrial fibrillation
• Pre existing left atrial fibrillation ablation
• Atrial fibrillation due to reversible cause
• Known intracardiac or other thrombi
• Pregnancy
• Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
• Contraindication for anticoagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Agilis sheeth group	Left atrial catheter ablation guided by introducer using Agilis sheeth	-
Non-steerable sheeth group	Left atrial catheter ablation guided by introducer using Non-steerable sheeth	-

Primary Outcome Measures

Name	Time	Method
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)	6 months post ablation

Secondary Outcome Measures

Name	Time	Method
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration	6 month post ablation

Trial Locations

Locations (1)

Herzzenturm Leipzig; 🇩🇪 Leipzig, Germany